## Two-stage design and 'forced bioequivalence' [Two-Stage / GS Designs]

Hi Mikalai,

'forced bioequivalence' - it's not from "that opera".

If you took for 2х2х2 n = 120 for CL AUCt (90-111.11 - with narrow therapeutic index), CV = 16.5% and recommended GMR = 97.5%, while in calculation (in R) for 2х2х4 you get n = 30.

The sample size is twice as high as possible, which is not ethical - to expose an unknown effect of the test drug to more people than necessary.

If I understand correctly, that's it 'forced bioequivalence'

regards

'forced bioequivalence' - it's not from "that opera".

If you took for 2х2х2 n = 120 for CL AUCt (90-111.11 - with narrow therapeutic index), CV = 16.5% and recommended GMR = 97.5%, while in calculation (in R) for 2х2х4 you get n = 30.

The sample size is twice as high as possible, which is not ethical - to expose an unknown effect of the test drug to more people than necessary.

If I understand correctly, that's it 'forced bioequivalence'

regards

### Complete thread:

- Two-stage design and 'forced bioequivalence' Mikalai 2018-06-06 08:28 [Two-Stage / GS Designs]
- Two-stage design and 'forced bioequivalence' ElMaestro 2018-06-06 10:53
- Two-stage design and 'forced bioequivalence'Yura 2018-06-07 10:24
- But what is the real problem? ElMaestro 2018-06-07 13:53
- But what is the real problem? Yura 2018-06-07 14:59
- But what is the real problem? Mikalai 2018-06-07 15:47
- But what is the real problem? Helmut 2018-06-07 17:33
- But what is the real problem? Mikalai 2018-06-08 12:24
- U as a futility criterion Helmut 2018-06-08 14:00

- But what is the real problem? Mikalai 2018-06-08 12:24

- But what is the real problem? Helmut 2018-06-07 17:33

- But what is the real problem? Mikalai 2018-06-07 15:47

- But what is the real problem? Yura 2018-06-07 14:59

- But what is the real problem? ElMaestro 2018-06-07 13:53

- Two-stage design and 'forced bioequivalence'Yura 2018-06-07 10:24

- Two-stage design and 'forced bioequivalence' ElMaestro 2018-06-06 10:53